Section outline
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Instructor Information Instructor Name : Md. Mizanur Rahman
Designation : Assistant Professor
Contact No. : 01304728507, 01556346870
Email : mizanur.ph@diu.edu.bd
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Due: Saturday, 21 January 2023, 9:36 PMStudents mustViewMake forum posts: 1
- You all are advised to keep notes and ask questions in this form.
- You can chat/talk/share knowledge freely in this section.
- Hope you all will help each other and make it fruitful.
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- All the students registered for this course have to enroll in Moodle
- Students can find all the course materials from Moodle.
- All the students have to submit the soft copy of their "Assignment" in Moodle under assignment section created here and for this they will be graded here.
- One discussion or feedback forum is created under each of the lecture Students have to give their feedback on these forum and marks will be given for their feedback
- Any announcement regarding the class will be posted on Moodle. So they have to keep themselves always active on Moodle.
- All the quizzes and presentation will be held on face to face class and may be few of the class will be held on online (Moodle) and it will be announced before the class
- The question pattern and the syllabus for the quizzes, midterm and final exam is given here under each of the section (quizzes, midterm and final)
- There are midterm and final exam preparation forum under these sections where students can discuss with each other about their midterm and final exam syllabus, any problem regarding the exam etc.
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Students mustMark as done
- All the students registered for this course have to enroll in Moodle
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Learning Outcomes:
- Explain Parenteral dosage form with their ingredients list
- Illustrate manufacturing procedure
- Evaluate critical parameters
- Design new formulation
Course Content:
Route of administration, selection of vehicles, added substances, containers, suspension and emulsion for injections, production facilities, environmental control, personnel, cleaning of containers and closures, sterilization of equipment, compounding the products, filtration of solutions, filling and sealing procedures, sterilization of products, various quality control tests for parenteral products
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Lecture -1 : Introduction to Parenteral Products
Learning outcome: Students will learn about
- Sterile dosages forms
- Merits and de-merits of Parenteral Products.
- General requirements of Parenteral Products.
- Route of Administration & Classification of Parenteral Products.
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Lecture-2: Formulation Design
Learning outcome: Students will learn about
- Preformulation studies required to design a parenteral products
- API
- Vehicles selection
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Students mustMark as doneLecture-3: Excipients for Parenteral
Learning outcome: Students will learn about
- Exicipients needed for manufacturing of Parenterals
- properties of exicipients,
- percentages of exicipients
- Common examples of exicipients
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Lecture-4: Manufacturing Process of Parenteral
Learning outcome: Students will learn about
Steps of Manufacturing Process of Parenteral dosage form
- Planning and preparation
- Compounding the product
- Filtration of solution
- Filling
- Sealing
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Lecture -5 & 6 : Sterilization & Packaging of Parenteral
Learning outcome: Students will able to learn about
- Sterilization process,
- Most effective process
- Packaging guideline
- Packaging technology of Parenteral
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Lecture -7 : Different Sterile Products
Learning outcome: Student will able to learn about
- Different type of Sterile Products
- IV admixture
- TPN
- Dialysis Fluid
- Irrigating solution
- Radio-pharmaceuticals
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Learning Outcomes:
- Explain the importance of a clean room
- List the component of HVAC system
- Classify clean room
- Describe the qualifying parameters
- Evaluate the best clean room
- Construct a clean room
Course Content:
Source of contamination, classification of clean rooms, airflow systems-conventional flow, unidirectional flow, laminar, airflow units; air filtration mechanisms, fibrous filters and HEPA filters, temperature and humidity control, building, construction and use, personnel, protective clothing, cleaning and disinfection, commissioning tests of clean and aseptic rooms, routine monitoring tests, the operation of clean and aseptic rooms, key factors in clean room operations.
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Students mustMark as doneLecture-1: Introduction to Clean Room Technology
Learning outcome: From this lecture student will get knowledge about
- General idea of Clean room
- Features
- Importance
- consideration for design
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Lecture-2: Design of Clean Room
Learning outcome: From this lecture student will get knowledge about
- How to design a Clean Room,
- Configure a clean room,
- Material of construction of a clean room
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Learning Outcomes:
- Explain Aerosol dosage form with their ingredients list
- Illustrate manufacturing procedure
- Compare best technique
- Find out best formulation
- Create new formulation
Course Content
Definition and classification of aerosols, propellants for aerosol manufacturing, components of aerosol formulations, containers and valves for aerosols, metered dose delivery of aerosols, manufacturing of aerosols, testing and quality assurance of aerosols.
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Lecture-1 : Introduction of Aerosol Science
Learning outcome: From this student will get knowledge about
- Basics of aerosol
- Merits and demerits
- Types
- Commonly used drug in aerosol
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Lecture-2 : Components of Aerosol
Learning outcome: From this lecture student will get knowledge about
Components of aerosol
- Propellant
- Container
- Drug concentrate
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Lecture-3 : Manufacturing of Aerosol
Learning outcome: From this lecture student will get knowledge about
- Manufacturing process
- Pressure Filling Process
- Cold Filling Process
- Compressed Gas Filling Process
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Learning Outcomes:
- Describe ophthalmic products with their ingredients list
- Illustrate different procedure
- Compare best technique
- Find out best formulation
- Develop new formulation
Course Content
Anatomy of the eye and adnexa, pharmacology and therapeutics of ophthalmic medication, general safety considerations, absorption of drugs in the eye; formulation of eye drops, eye lotions, eye ointments: preparation, sterilizing, packaging; contact lens care products
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Lecture-I : Introduction of Ophthalmic Products
Learning outcome: Students will learn about
- Introduction
- General requirements
- Types
- Guide to use
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Lecture-II : Formulation
Learning outcome: Students will learn about
- Ingredients
- Formulation design
- Process of manufacturing
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Learning Outcomes:
- Explain Pilot plant and scale-up techniques
- Illustrate general consideration
- Identify critical parameters for all dosages form
- Design new formulation
Course Content
Introduction, selected factors to be considered during development, types of organizational structures responsible for pilot operations, educational backgrounds of pilot plant personnel, pilot plant design for tablet development, use of the pilot plant scale-up to select the optimal procedure, problems caused by a change in excipient supplier, process variables and measures to overcome.
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Lecture : Pilot Plant
Learning outcome: Students will learn about
- Basics
- Importance
- General considerations
- Critical parameters of different dosage form
- PO/MO, BMR, SOP, STP
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Learning Outcomes:
- Describe types, importance, characteristics of packaging materials
- Illustrate different procedure of packaging
- Compare best technique
- Design new packaging materials
Course Content
Types of containers, materials used, closures, unit dose packaging, strip packaging materials, packaging of solid, parenterals and ophthalmic dosage forms, packaging of other dosage forms, stability aspects of packaging.
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Lecture on Packaging Technology
Learning outcome: Students will learn about
Importance- Criteria
- FDA, BP, USP guideline
- Different Packaging materials
- Process of Packaging technology
- Evaluation of Packaging materials
